A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in terms of clinical and microbiological response in treatment of impetigo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lytix Biopharma AS

Criteria

Inclusion Criteria:

• Patients ≥ 2 years of age.

• Signed written informed consent document by patient, parent, legal guardian or caretaker.

• Positive Gram-stain of target lesion showing Gram-positive cocci.

• Clinical diagnosis of primary non-bullous impetigo as per protocol.

• Candidate for treatment with topical antibacterial and have a Skin Infection Rating Scale (SIRS) of ≥ 4 with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus.

• Total lesion area ≤ 20 cm2. Single lesion not to exceed 2 cm2.

• No known medical conditions that in the investigators opinion may interfere with study participation or put the patient at additional risk.

Exclusion Criteria:

• Unwillingness or inability of patient, parent, legal guardian or caretaker to comply with the requirements of the protocol.

• Presence of other skin disease at or near the investigational target area to be treated.

• The disease is so widespread or severe that, in the opinion of the investigator, the patient needs oral antibiotic treatment.

• History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease.

• Concurrent or recent scabies infection.

• Signs and symptoms of a current infection requiring antibiotic treatment.

• Tympanic temperature at Baseline > 38 °C (100.4 °F) in a pediatric patient or 37.8 °C (100 °F) in an adult patient.

• Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry.

• Participation in any other clinical study or use of any other investigational drugs or investigational device within 30 days prior to treatment.

• Known allergy to any constituent of the study medication.

• Presence of secondarily-infected animal/human/insect bite or infected burn wound.

• Other reason which based on the discretion of the investigator makes the patient unsuitable for enrolment.

• Lactating or pregnant.